WO2004069317A1 - Systemes a gaz et procedes pour permettre une stabilite respiratoire - Google Patents

Systemes a gaz et procedes pour permettre une stabilite respiratoire Download PDF

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Publication number
WO2004069317A1
WO2004069317A1 PCT/US2003/037236 US0337236W WO2004069317A1 WO 2004069317 A1 WO2004069317 A1 WO 2004069317A1 US 0337236 W US0337236 W US 0337236W WO 2004069317 A1 WO2004069317 A1 WO 2004069317A1
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WO
WIPO (PCT)
Prior art keywords
gas
concentration
modulation system
patient
carbon dioxide
Prior art date
Application number
PCT/US2003/037236
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English (en)
Other versions
WO2004069317A8 (fr
Inventor
Robert J. Thomas
Robert W. Daly
Original Assignee
Beth Israel Deaconess Medical Center, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beth Israel Deaconess Medical Center, Inc. filed Critical Beth Israel Deaconess Medical Center, Inc.
Priority to CA002514481A priority Critical patent/CA2514481A1/fr
Priority to MXPA05008071A priority patent/MXPA05008071A/es
Priority to AU2003291817A priority patent/AU2003291817B2/en
Priority to JP2004568008A priority patent/JP2006513004A/ja
Priority to AT03769002T priority patent/ATE434459T1/de
Priority to DE60328133T priority patent/DE60328133D1/de
Priority to EP03769002A priority patent/EP1590029B1/fr
Publication of WO2004069317A1 publication Critical patent/WO2004069317A1/fr
Publication of WO2004069317A8 publication Critical patent/WO2004069317A8/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0045—Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M16/101—Preparation of respiratory gases or vapours with O2 features or with parameter measurement using an oxygen concentrator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/202—Controlled valves electrically actuated
    • A61M16/203—Proportional
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0042—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the expiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/1025—Measuring a parameter of the content of the delivered gas the O2 concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/103—Measuring a parameter of the content of the delivered gas the CO2 concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/17—General characteristics of the apparatus with redundant control systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8218—Gas operated
    • A61M2205/8225—Gas operated using incorporated gas cartridges for the driving gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/914—Rebreathing apparatus for increasing carbon dioxide content in inhaled gas

Definitions

  • SDB sleep disordered breathing
  • xPAP therapy is often highly effective in treating non-complex obstructive SDB
  • patients with more complex disease usually fail xPAP therapy.
  • Such patients typically have evidence of overt or subtle periodic breathing and may have a mix of obstructive apneas, hypopneas and central apneas. Often, these patients will be more unstable during non-REM versus REM sleep. Even with the addition of oxygen to PAP these patients as a group are very difficult to treat.
  • the inventors of the present invention have re-visited the use of carbon dioxide (C02) as a sleep-breathing stabilizer by designing and testing (for safety and efficacy) a prototype device that can provide precise concentrations of CO2 and oxygen (02).
  • the prototype device is designed to operate in conjunction with existing xPAP equipment, although it may be used alone or with other treatment modalities.
  • the present invention provides (i) a substantially low concentration carbon dioxide and pressurized air gas mix, and (ii) a device for stabilizing breathing using the pressurized air and carbon dioxide gas mix delivered to a patient centric ventilatory space module (PCVSM) for use (inhalation) by a target.
  • Concentration of CO2 in the gas mix is less than 2% and preferably between about .5% and 1.25%.
  • a prototype and first embodiment of the present invention includes a mobile (selectably moveable) cart or other suitable housing, on which are installed (i) a CO2 source, (ii) a gas-mixing chamber or module receiving the source CO2, as well as O2 from a separate oxygen concentrator, (iii) CO2 and 02 monitors on the output side of the gas-mixing module, and (iv) a control processor with appropriate software and display system, coupled to receive signals f om the monitors and sensors via a multi-function input box and coupled to control input and output valves of the gas-mixing module. Further, an electrically actuated proportional valve, controlled by the control processor, is employed between the CO2 source and gas mixing module, or in the gas mixing module.
  • a limiting orifice consisting of a needle valve is placed in series with the proportional valve and provides for a maximum flow rate and thus concentration of CO2,
  • the system offers redundant C02 monitoring capability as well as 02 monitoring.
  • the flow of CO2 into the gas mixing chamber is controlled by a calibrated electrically actuated proportional valve, and is measured by a visually readable variable area glass flow meter.
  • the actual concentration of CO2 in the mixing chamber is measured by a patient monitor such as a Datex/Ohmeda Capnomac monitor incorporating both C02 and 02 sensors, and the final concentration of CO2 at the patient interface is measured using a mainstream CO2 sensor such as the Nihon Kohden TG951T CO2 sensor.
  • the Nihon Kohden sensor also provides a value for end-tidal CO2 (etCO2), thought to be the most direct measure of CO2 concentration in the alveoli of the lungs.
  • etCO2 end-tidal CO2
  • the purpose of the multiple redundant sensors is to ensure the safe delivery of appropriate concentrations of CO2 and oxygen to the patient.
  • the monitoring of gas concentrations is further enhanced by the incorporation of a sensor that directly measures gas concentrations in the patient's blood.
  • a transcutaneous monitor such as a Sensormedics Microgas 7650, provides measurement of the partial pressure of both oxygen and CO2 in the patient's arterial blood.
  • the parts, i.e., connectors, tubes, pipes, are assembled in a modular tray or box that can bolt in or out of the rack.
  • a patient monitor unit such as a Datex/Ohmeda Capnomac unit, is calibrated and provides, but is not limited to, analog and digital waveforms such as the following: a) Analog: CO2 waveform and O2 waveform (Ov to +10v); b) Digital: inspired C02, etCO2, inspired 02, Alarm States, Time, Ambient Pressure.
  • the "normally off" proportional valve is preferably a stainless steel or brass proportional valve that controls flow of the CO2 supply to the gas mixing chamber.
  • the valve is energized via a power voltage from a power supply and by a control voltage, which is generated by the control processor, or in a prototype embodiment, from a computer running the DASYLab (see www.dasylab.net dasylab_english) data acquisition system.
  • a multi-function input box is preferably a signal box built with a signal input card.
  • One example, built by IOTech (www.iotech.com) has sixteen single-ended analog inputs, of which eight are single-ended inputs available via screw connectors.
  • the software used for display and for providing an experimental workspace is DASYLab (Data Acquisition System Laboratory) running on a P4 computer with 1 GB SDRAM and over 80 GB hard drive space.
  • DASYLab Data Acquisition System Laboratory
  • a basic set of screens/worksheets for operating the machine have been created, under which the data from the gas mixing module are monitored, alarms are triggered, the C02 supply valve is adjusted and the whole session is recorded.
  • a patient monitoring screen records C02 as detected at the patient delivery end (e.g., facemask) and displays the values on the screen in real time.
  • a standard xPAP unit connects to the input side of the gas-mixing module via standard respiratory tubing.
  • Standard respiratory tubing leading from the output side of the gas mixing module is led to the patient, with an optional heated humidifier interposed between the system and the patient.
  • the tubing is connected to a "Y" connector, one of the other legs of the "Y" connector being attached to a length of standard respiratory tubing, the exhaust tubing.
  • the exhaust tubing returns to the system via an exhaust port on the front of the mixing module, where the exhaust bleed rate is controlled by a variable orifice comprising a manually operated needle valve or a processor controlled proportional valve, or the like.
  • the third part of the "Y" connector is attached to the detector module of the Nihon Kohden sensor.
  • the Nihon Kohden sensor is attached to a substantially sealed oronasal or nasal xPAP mask.
  • the purpose of this configuration is to avoid dilution of the exhaled C02 before it is measured by the Nihon Kohden sensor, thus permitting accurate measurement of etCO2.
  • the output of the gas mixing module can be connected to other patient-centric ventilatory space modules (PVCSM's) such as an incubator, an unsealed mask, a tent or a nasal canula.
  • PVCSM's patient-centric ventilatory space modules
  • One or more pneumotachographs are optionally inserted into the breathing circuit at various locations, including the hose connecting the system to the "Y” fitting, between the “Y” fitting and the Nihon Kohden sensor, or between the "Y” fitting and the exhaust port on the system.
  • Each pneumotachograph is connected via specialized tubing to a dedicated pressure transducer, the voltage output of which is proportional to the flow rate of gas through the pneumotachograph. The voltage from the pressure transducer is read by the system controller and is recorded.
  • the purpose of the pneumotachographs is to measure either or both of, system operating parameters such as air flow through the mixing chamber, exhaust bleed rate, or patient physiological parameters, particularly respiration. These data may be used to control various operating parameters of the system.
  • a gas modulator, a gas regulator or other gas delivery system includes a gas mixing module (generally gas mixing means), a sensor and a control processor.
  • the gas mixing module mixes plural gases, including a first gas such as carbon dioxide (CO2), into a gas mix, for delivery to a substantially leak-proof patient centric ventilatory space module (PCVSM), such as an incubator; a tent; a facemask; and a nasal cannula.
  • a sensor located substantially at the PCVSM, measures concentration of the first gas in the PCVSM.
  • the control processor based on a signal from the sensor, controls the concentration of the first gas in the gas mix.
  • the first gas may be supplied from a pressurized source, and the gas modulator may further include a control valve module, which regulates flow of the first gas from the pressurized source to the gas mixing module, in response to a control signal from the control processor.
  • the control valve module may be, for example, a normally-off solenoid valve, or a proportional valve.
  • a limiting orifice may be arranged in series with the control valve.
  • the gas mixing module consists of a small box (mixing chamber) having an input plenum, an output plenum and a flow channel which connects the input plenum to the output plenum.
  • the three chambers are formed by a T-shaped baffle in one embodiment.
  • a flow meter on the input side of the gas mixing module provides a visual and/or electrical indication of flow of the first gas into the gas mixing module.
  • a flow meter on the output side provides a visual and/or electrical indication of flow of bleed air vented from the PCVSM.
  • the gas modulator may contain a proportional valve that is responsive to a control signal from the control processor, which regulates exhaust bleed air vented from the PCVSM.
  • the control processor can thus dynamically control the proportional valve in response to detected system changes, such as physical changes in the mask seal.
  • bleed air may be controlled via a manually operated needle valve.
  • Pressurized air may be a second gas with which the first gas is mixed.
  • the gas modulator may further include a positive airway pressure (PAP) module that produces the pressurized air, the pressurized air being delivered from the PAP module to the gas mixing module via a tube.
  • PAP positive airway pressure
  • the control processor may be additionally responsive to patient state information from any combination of: thermistors, strain gauges, pneumotachographs and physiological signals, including for example, EEG and EKG signals.
  • the gas modulator may further include any or all of, but is not limited to: a transcutaneous blood gas monitor that measures partial pressure, in a patient, of one or more gases, including the first gas; a pressure sensor, mounted in proximity to the PCVSM, that measures inspired and expired breath volume; a skin conductance monitor that measures skin conductance; and an arterial contraction monitor that monitors the state of contraction of small arteries in a patient's finger.
  • a transcutaneous blood gas monitor that measures partial pressure, in a patient, of one or more gases, including the first gas
  • a pressure sensor mounted in proximity to the PCVSM, that measures inspired and expired breath volume
  • a skin conductance monitor that measures skin conductance
  • an arterial contraction monitor that monitors the state of contraction of small arteries in a patient's finger.
  • Each of these devices provides a signal to the control processor, which uses the information to determine and/or control the concentration of the first gas in the gas mix.
  • a display monitor may be connected to the control processor, so that the control processor can display, for example, an
  • a first indicator may show the concentration of CO2, while a second indicator shows the concentration of 02.
  • a scrolling chart recorder may be displayed to indicate the value of at least one parameter of interest, including, but not limited to: C02 concentration; 02 concentration; control processor control state; a sensor signal; or a physiological signal.
  • An embodiment of the gas modulator includes a remote interface through which the control processor is remotely controllable from a remote workstation.
  • the connection to the remote workstation may be, for example, a wireless TCP/IP connection, or may be wired, or may use another protocol.
  • the gas modulator can also include an audio recording and analysis module to record and analyze audio signals from one or more microphones attached to a patient.
  • a gas sampling sensor can monitor the concentration of one or more gases, including the first gas, within the gas mixing module.
  • the gas sampling sensor provides a signal to the control processor, which the control processor analyzes in controlling the concentration of the first gas in the gas mix.
  • the gases may be carbon dioxide (C02) and oxygen (02).
  • an input flow sensor measures flow of the first gas into the gas mixing module.
  • the input flow sensor provides a signal to the control processor, which analyzes the signal to control the concentration of the first gas in the gas mix.
  • a PCVSM bleed air sensor can measure flow of PCVSM bleed air.
  • the PCVSM bleed air sensor provides a signal to the control processor, which analyzes the signal to control the concentration of the first gas in the gas mix.
  • One or more pneumotachographs connected to pressure transducers, measure air flow in various parts of the breathing circuit, such as air flow through the mixing chamber, exhaust air, and patient respiration. Output from the pressure transducers is proportional to air flow and is read by the control processor.
  • a pneumotachograph can be placed within the mixing chamber itself between the input plenum and the output plenum.
  • control processor continuously receives and analyzes incoming data and indicates an alarm condition based on the incoming data and one or more of the following (and possibly other) parameters: maximum C02 flow; maximum C02 concentration in the mixing chamber, maximum inspired C02; maximum arterial C02; and maximum end-tidal C02. Delivery of C02 is reduced or halted when an alarm condition is present. Furthermore, a visual or audible alarm may be sounded when an alarm condition is present.
  • the PCVSM consists of a substantially sealed oronasal or nasal xPAP mask which is designed to eliminate dilution of exhaled air so that accurate measurements of C02 concentrations in exhaled air can be made.
  • the control processor can thus determine, from the sensor located substantially at the PCVSM, end-tidal C02 concentration (that is, the C02 concentration just as the patient finishes exhaling) as well as inspired C02 concentration, the average C02 concentration as the patient breathes in.
  • et C02 concentration provides data about the patient's blood levels of C02.
  • Inspired C02 concentration indicates the level of C02 that the inventive device is delivering.
  • the control processor can thus control the concentration of C02 for a variety of patients, including those diagnosed as having sleep disordered breathing (SDB) or Cheyne-Stokes respiration, those diagnosed as having had an "Apparent Life Threatening Experience” (ALTE), and those diagnosed as having apnea of prematurity.
  • SDB sleep disordered breathing
  • ATE Alterarent Life Threatening Experience
  • An embodiment of the gas modulator of the present invention includes a memory for recording a history of data/signals received by the control processor and control signals generated by the control processor.
  • the gas modulator is intended for a non-clinical setting.
  • the first incoming gas may be contained in a canister having an orifice of a size which determines maximum flow according to a specified limit.
  • This embodiment may further include recording and reporting means, which may be remotely accessible, for example, via a dial-up connection.
  • C02 is generated by accumulating the patient's own C02 in a deadspace.
  • a valve is regulated to adjust the C02 concentration in the deadspace from which the patient is breathing.
  • This embodiment may comprise a carbon dioxide regulator which includes a positive air pressure (PAP) module, a sensor, and a control processor.
  • PAP positive air pressure
  • the PAP module delivers pressurized air to a substantially leak-proof mask to be worn by a patient.
  • the sensor located substantially at the patient mask, measures concentration of carbon dioxide in the mask, the concentration dynamically changing in response to the patient's breathing.
  • the control processor receives signals from the sensor and, based on a signal from the sensor, controls an exhaust vent (via, for example, a proportional valve) connected to the mask to control the level of carbon dioxide in the mask.
  • the present invention provides the combination PAP (pressurized air) and low concentration C02 (less than 2% and preferably about .5% to about 1.25%) for effecting respiratory stability (as a method of treatment, a device/machine/system, a gas product and/or a computer program product) heretofore unachieved by the prior art.
  • Fig. 1 is a schematic diagram of the input side of an embodiment of the present invention.
  • Fig. 2 is a schematic diagram of the output side of an embodiment of the present invention.
  • Fig. 3 is a schematic diagram of the control processor system of an embodiment of the present invention.
  • Fig. 4 illustrates a sample display screen of an embodiment of the present invention.
  • Fig. 5 is a schematic diagram of a variable deadspace embodiment of the present invention.
  • a description of preferred embodiments of the invention follows.
  • a prototype of an embodiment of the present Positive Airway Pressure Gas Modulator (PAPGAM) invention has been built as an investigational medical device, the purpose of which is to deliver precisely metered doses of carbon dioxide gas (C02), oxygen (02), and potentially otlier inhalational agents to patients who are also being treated with positive airway pressure (PAP).
  • C02 carbon dioxide gas
  • oxygen 02
  • PAP positive airway pressure
  • the PAPGAM was designed to meet the need for such an instrument in treatment of unstable breathing, including sleep apnea, periodic breathing and central apnea. These conditions affect millions of people worldwide and result in substantial morbidity and mortality.
  • Fig. 1 is a schematic diagram of the input side of an embodiment of the invention.
  • a C02 gas source consists of a pressurized canister 2 of medical grade C02 gas; for example, a five-pound steel canister that may be mounted on the side of the PAPGAM rack.
  • the pressure from the canister is regulated to an appropriate delivery value (approximately 10-40 PSIG) by virtue of an adjustable dual indicator mechanical pressure regulator 150 that is attached directly to the outlet 3 of the canister 2.
  • a lever-operated shut-off valve 152 enables manual cut-off of the C02 supply.
  • the control valve module 4 modulates the flow of C02 gas in response to a control signal 10.
  • the module 4 includes a valve 6, for example a Pneutronics VSO electrically-actuated proportional valve, which is energized by DC current 155 at 12V and a 0V-10V conttol signal 10 from the control processor 100.
  • the control voltage determines the size of the effective orifice of the proportional valve 6 and thus the flow of C02. When the control voltage is less than one volt or the supply of current is completely interrupted, no C02 can flow through the valve 6.
  • the input orifice of the valve 6 is connected to the manual shut-off valve 152 by an appropriate length of medical grade tubing.
  • control valve module 4 is fabricated and mounted in a polycarbonate enclosure to further provide isolation from the chassis of the instrument.
  • control valve 6 comprises a "normally off solenoid valve that permits binary (on-off) control of C02 according to a control signal 10 received from the control processor 100.
  • the output orifice of the valve 6 is connected by tubing to a turbine-type flow meter 8 which measures the amount of C02 leaving the control valve 6.
  • the flow meter 8 outputs a variable analog voltage signal 12 that is proportional to the flow. This signal 12 is electrically routed to the control processor 100 via signal interface 114 (Fig. 3). Input mechanical flow controller / indicator
  • a mechanical flow controller/indicator 14 comprising (i) a variable area glass flow indicator 158, allows visual measuring of C02 flow, and (ii) a manually operated needle valve 156 which determines a maximum flow rate of C02 when the proportional valve 6 is fully open.
  • this controller/ indicator 14 is mounted at the input side of the gas mixing module 20, described below. Its input orifice is connected to the valve control module 4 via a short length of tubing 157. Its output orifice is ducted directly into orifice 22 of the input plenum 82 of the gas mixing module 20.
  • Gas mixing module comprising (i) a variable area glass flow indicator 158, allows visual measuring of C02 flow, and (ii) a manually operated needle valve 156 which determines a maximum flow rate of C02 when the proportional valve 6 is fully open.
  • this controller/ indicator 14 is mounted at the input side of the gas mixing module 20, described below. Its input orifice is connected to the valve control module 4 via a short length of tubing 157. Its
  • the gas mixing module 20 mixes pressurized air supplied from a medical positive airway pressure device (xPAP) 18 with the C02 gas delivered from the valve control module 4, and with oxygen (02) delivered from an appropriate source 16, such as an oxygen concentrator or bottled oxygen.
  • xPAP medical positive airway pressure device
  • oxygen 02
  • the gas mixing module 20 consists of a polycarbonate box approximately 10 cm H 10 cm H 20 cm which contains a T-shaped internal baffle 80.
  • the baffle 80 creates three connected spaces within the gas mixing module 20. These three spaces include an input plenum 82, a flow channel 84 and an output plenum 86. All incoming gases are conducted into the input plenum 82 via orifices 22, 24, 26.
  • the flow channel 84 connects the input plenum 82 to the output plenum 86.
  • the output plenum 86 provides various outlets (see Fig. 2) through which the mixed gases (i.e., the gas mix) exit the gas mixing module 20.
  • the gas mixing module 20 is mounted to a 19" rack mount aluminum faceplate.
  • the faceplate is drilled to accommodate mounting screws for the polycarbonate box as well as the various fittings appropriate to each orifice, including, on the input side: a standard green plastic nipple fitting 24 to which the oxygen supply 16 is connected; and a standard 22 mm male fitting 26 for hose connection to the xPAP 18.
  • the entire unit is mounted as an assembly to the PAPGAM cart (housing) via four screws through the 19" faceplate.
  • Fig. 2 is a schematic diagram of the output side of an embodiment of the invention. On the output side of the gas mixing module 20 are three output connections
  • hose barb fitting 28 for connecting a gas-sampling line
  • a 0.5 inch brass hose barb fitting 32 for measurement of chamber pressure via a connection to a pressure transducer 170
  • a standard 22 mm male fitting 30 for hose connection to the breathing / respiratory circuit 70.
  • a gas sampling monitor or sensor 36 for example, a Datex Capnomac gas monitor, constantly monitors the concentration of oxygen and C02 in the gas mixing module 20, by sampling the gas in the output plenum 86 via the gas sampling port 28.
  • the gas monitor 36 exports data to the control processor 100 through an analog output, or alternatively, an RS-232 interface (collectively 56).
  • an analog output or alternatively, an RS-232 interface (collectively 56).
  • RS-232 interface collectively 56
  • a pressure transducer or manometer 170 measures the pressure of the gas mix within the output plenum 86 via the chamber pressure port 32. Pressure data is then sent to and analyzed by the control processor 100 via signal 172.
  • Pressurized air at the proper C02 and 02 concentrations is supplied from the output plenum 86 of the gas mixing module 20 to the respiratory circuit 70 via an appropriate length of tubing (air supply hose) 38 connected to the main output port 30.
  • the respiratory circuit 70 including the mask 48, differs from a typical xPAP circuit in several key respects.
  • the mask 48 itself is designed to be as leak-proof as possible, to provide an accurate end-tidal C02 reading. This has necessitated modifying a standard xPAP mask by sealing the various sources of leaks including the ventilation ports, swivel comiections and joints between the mask body and facial pillow.
  • a C02 sensor 42 is placed directly in the respiration circuit 70; for example, it may be mounted directly to the surface of the mask 48 by means of a 90-degree swivel fitting (not shown).
  • this sensor 42 is a Nihon Kohden (NK) TG951T mainstream C02 sensor, which is compact and lightweight, and which can measure C02 concentrations in the patient's breath (inhaled or exhaled) at a sampling rate of about 40 Hz.
  • the NK sensor 42 utilizes an infrared spectrometry principle and provides very high resolution, accuracy, and resistance to fogging and clogging. It outputs an RS-232 serial data stream 44 that is received and processed by the control processor 100.
  • the C02 sensor 42 is the principal means of measuring physiological response to the PAPGAM invention system in real time.
  • Other sensors, capnographs and the like may be used for sensor 42 (for example, Tidal Wave Sp by Novametrix).
  • the data from the C02 sensor 42 is, for example, a 9600 baud serial data stream which is received by the control processor 100.
  • WinWedge software (described below) parses the data stream and delivers it via a DDE hotlink to DASYlab.
  • a pneumotachograph 160 may be mounted directly to the NK sensor
  • Pneumotachograph 160 Pressurized air at the proper C02 and 02 concentrations is supplied to the proximal end of the pneumotachograph 160 by means of a flexible air supply hose with standard female 22mm adapters on each end.
  • Pneumotachograph 160 is a flow meter, generally of the pitot -tube type. Other types of flow meters are suitable.
  • Bleed air from the respiratory circuit 70 is exhausted via a return (exhaust) hose 50.
  • the air supply hose 38, bleed air hose 50, and mask/NK/pneumotachograph assembly are connected by a three-way "Y" adapter 40.
  • the exhaust air control system 180 consists of a glass flow meter 164, a proportional valve 52, an electronic turbine meter 54 and exhaust ducting 55.
  • the glass flow meter 164 allows visual measuring of bleed air from the respiration circuit 70. Bleed air is ducted from the mask 48 to the glass flow meter 164 via the exhaust hose 50.
  • the proportional valve 52 controls the flow of exhaust, in response to a control signal 53 from the computer 100. This allows the computer to intelligently and dynamically adjust the exhaust flow to compensate for changes over time, for example, should the quality of the of the mask seal change.
  • exhaust bleed flow is adjusted by means of a manually operated needle valve.
  • a mask bleed sensor 54 measures flow of the bleed air from the respiratory circuit 70.
  • This sensor 54 may be a turbine flow meter which measures the bleed air after the bleed air passes through the mechanical flowmeter 164.
  • the mask bleed sensor 54 provides an electronic signal 58 to the control processor 100 for analysis, in part to maintain the correct gas mixture.
  • the bleed air is ducted away from the unit 52 via a length of flexible hose 55 that, in one embodiment, passes out through the rear of the cart.
  • CONTROL PROCESSOR / SIGNAL INTERFACE Fig. 3 is a schematic diagram of the control processor system.
  • the signal interface unit 114 provides an electrical interface between the various sensors incorporated into the invention PAPGAM and the input/output (i.e., data acquisition) circuit board 102 in the control processor 100.
  • the signal interface unit 114 in the prototype consists of the following elements, although it would be recognized by one skilled in the art that functional equivalents could be substituted where appropriate.
  • An Iotech DBK 207 signal conditioning board 272 which contains 16 slots for inserting 5-B compatible isolated analog signal conditioning modules appropriate to each type of sensor;
  • the signal interface unit 114 can be configured in a variety of ways to route both digital and analog signals to and from the control processor 100 to various sensors, including the control valve 6, the C02 flow meter 8, the gas mix monitor 36, the pneumotachographs 160, sound recording equipment 108, as well as other laboratory equipment and sensors 190.
  • the signal interface unit 114 can be configured to accept virtually any type of sensor signal including thermistors, strain gauges, or very low voltage physiological signals such as EEG or EKG signals.
  • the control processor 100 incorporates a microcomputer and data acquisition card 102.
  • the microcomputer is an AMD Athlon XP 1800+ CPU mounted on an ASUS A7V266 motherboard utilizing the VTA KT-266 chipset. 1 GB of certified EC DDR SDRAM is installed.
  • the computer is housed in an industrial steel 19" 3U high rack mount enclosure incorporating internal and external cooling fans.
  • Peripherals installed in the computer include: -3.5" Floppy disk drive (not shown);
  • the control processor 100 is equipped with an Iotech DaqBoard 2000 PCI bus data acquisition circuit board 102.
  • the DaqBoard 2000 is capable of sampling and digitizing 16 single-ended or eight bipolar analog input signals at 200 kilohertz, 16- bit resolution. In addition, it has provision for two analog output signals and forty digital I/O lines, as well as a number of additional counter functions.
  • the Daq2000 card is connected to the DBK 201 board 270 in the signal interface unit 114 by means of a ribbon cable 115.
  • the signal interface unit 114 may be incorporated with the control processor 100 into a single unit.
  • the computer display 112 is a Viewsonic 15" flat panel LCD display that is attached to the PAPGAM cart by a flexible monitor arm (not shown).
  • control processor 100 runs under the Windows XP Professional operating system.
  • the principle application providing control of the invention system (PAPGAM) is National Instruments DASYlab version 7.0. DASYlab provides a complete development and runtime environment for creating complex monitoring and control systems. A custom "worksheet" and screen display has been created within DASYlab that provides for monitoring of all instrument functions.
  • DDE Microsoft Dynamic Data Exchange
  • an RS-232 wedge application is available to run under Windows XP.
  • TALtech Technologies WinWedge Pro is a serial data acquisition program that can be configured to act as a DDE server.
  • DASYlab it is possible to configure a data module that acts as a DDE client and that queries WinWedge Pro for the values of selected data fields.
  • the PAPGAM can also be configured to be a complete post-acquisition review workstation.
  • National Instruments' DIAdem, running under Windows XP provides both data review and visualization capabilities as well as sophisticated signal processing and mathematical manipulation features.
  • the invention system (PAPGAM) is controllable remotely from another workstation via a wireless (or alternatively, wired) TCP/IP connection 110 using the Remote Desktop feature of Windows XP Professional.
  • a LinkSys USB wireless Ethernet receiver/transmitter performs this function.
  • An embodiment of the PAPGAM also incorporates a highly sophisticated digital audio recording and analysis package 106, such as Cakewalk Sonar II, which provides multi-track digital recording, filtering visualization and playback.
  • Sensitive microphones 108 attached to the patient can be connected through the signal interface module 114 and/or the Soundblaster card for recording under Sonar II.
  • a steel rackmount enclosure measuring 19" wide by 19" deep by 36" high for example, is mounted on lockable caster wheels.
  • the gas mixing module 20 and the control processor 100 are mounted in the enclosure or cart.
  • the enclosure may consist of a relatively small and lightweight unit.
  • the control processor 100 / signal interface 114 can accept input from virtually any type of physiological sensor able to output an analog or digital signal.
  • embodiments of the present invention may include some or all of the following types of physiological sensors as part of the overall invention system (PAPGAM) montage. While specific brands and models are listed, it would be understood by one skilled in the art that other models by other manufacturers which perform essentially the same functions could be substituted.
  • PAEM overall invention system
  • a ttanscutaneous blood gas monitor (not shown), such as the advanced Sensormedics Microgas 7650 ttanscutaneous blood gas monitor or Novamefrix TC02M ttanscutaneous monitor, or the like, can provide non-invasive measurement of arterial partial pressure of oxygen and C02. It utilizes a heated surface probe that is attached to the patient via a disposable adhesive circular strip.
  • the unit is self-calibrating and has data ports for both serial and analog outputs. This unit can be used in conjunction with the invention PAPGAM system in a clinical setting for safety, diagnostic and titration purposes.
  • a Braebon Ultima Plus Dual Channel Pressure Sensor (not shown) and Datex-Ohmeda D-Lite Pneumotachograph 160 (Fig. 2) can work in conjunction in a variety of possible configurations to provide the PAPGAM with air flow and pressure data.
  • the pneumotachograph 160 is mounted in proximity to the patient mask 48 to provide data about inspired and expired breath volume.
  • the Braebon unit interprets the pressure data from the D-Lite sensor and outputs two analog voltage signals 162 which represent the flow and pressure data. These are routed to the signal interface unit 114 via mini audio jacks located on the front panel.
  • the PAPGAM prototype has been designed for use principally during a sleep study to detennine the appropriate prescription for C02 gas and 02 gas in conjunction with xPAP therapy for patients suffering from periodic breathing.
  • PAPGAM neurode-specific integrated circuit
  • the PAPGAM sensors including the Sensormedics ttanscutaneous unit, the NK sensor, the D-Lite/Braebon sensors, etc., can be applied to the patient.
  • PAPGAM expressed in percent C02.
  • the PAPGAM will prompt the clinician for a number of data items, including patient infonnation and alarm limits for a number of parameters, such as:
  • Fig. 4 illustrates a sample display screen 500.
  • the clinician can initiate recording from the main display screen 500 by selecting (e.g., clicking on) a screen button 203. Once recording has been initiated and all other clinical procedures are complete, the clinician initiates delivery by adjusting the C02 setpoint by moving the software slider 205 up or down and turning on the valve 6 switch (software button 201).
  • DASYlab evaluates incoming data for detection of alarm states. Should any of the input parameters be exceeded, an alarm condition will be called and an indicator 207 will turn red on the screen. The existence of any alarm state may cause the control valve 6 (Fig. 1 ) to shut off or reduce flow of C02 until the alann state is cleared, or they may simply notify the operator of the existence of an alarm condition.
  • Two software level indicators 209, 211 display the actual percent C02 and percent 02 concentrations respectively, which are sampled from the output plenum 86 of the gas mixing module 20, providing visual verification that the gas mix remains at the target concentration.
  • a scrolling chart recorder 221 can display various parameters of interest, including C02 mix, 02 mix, valve state, physiological signals being received and so forth. As the study progresses, the clinician may wish to change the C02 dosage.
  • a further embodiment may include an audio alarm at the nursing station to alert personnel as to any alarm state, including an underdose.
  • all parameters are stored in a file in proprietary DASYlab format.
  • These files can be further analyzed and processed post-study. They can also be output in a variety of formats for display and analysis in other applications.
  • PAPGAM CLINICAL A clinical PAPGAM embodiment is intended for use primarily in a clinical setting, particularly a sleep laboratory. It permits operator adjustment of C02 and air bleed parameters, can record detailed information as does the current prototype, and can output reports in set formats.
  • the unit may have a "cart" form factor (housing) and may be remotely operable.
  • PAPGAM HOME A "home" unit embodiment is intended for a non-clinical setting, such as a patient's home.
  • the home unit is not user adjustable, but can be programmed by a home care technician according to a physician's prescription. It has a simple on/off switch and a number of status indicators.
  • the C02 source can be incorporated directly into the unit by means of a screw-in type canister or it can be connected via tubing.
  • the canister itself may have an orifice sized to limit flow to a maximum specification.
  • the home unit may incorporate simplified recording and reporting capabilities which are accessible remotely by a clinician, e.g., via a dial-up connection. This unit can have a form factor that is as compact as possible, preferably a bedside tabletop size that fits under the patient's xPAP unit.
  • VARIABLE DEADSPACE MASK Fig. 5 is a schematic diagram of a variable deadspace embodiment 400 of the present invention.
  • One purpose of this embodiment of the present invention is to raise the C02 concentration of air being delivered from a cPAP machine to a target value without the use of supplemental C02. This is accomplished by causing the patient to rebreathe his own C02 from a reservoir (deadspace) 403 attached to a mask 401.
  • the reservoir 403 may, for example, consist of a length of hose (the deadspace hose) with a capacity of approximately 500 ml. Ordinarily, no air should leak from the deadspace hose/mask combination.
  • the patient's own C02 is accumulated in this reservoir 403, so he rebreathes it.
  • the average inspired concentration of C02 from the hose/mask combination begins to exceed the desired level, the average concentration of inspired C02 is limited by permitting air to be vented out of the mask 401, for example at inlet 417, down through a flexible tube 405 and out through a variable orifice.
  • the variable orifice may comprise, for example, a small proportional valve 407 operated by a computer 413 that receives C02 concentration information 411 from a C02 sensor 409, for example, the same type of mainstream (Nihon Kohden) C02 sensor discussed previously.
  • the sensor 409 monitors the C02. Once the C02 concentration reaches the desired target level, the valve 407 begins to open in order to keep the C02 concentration from going over target level.
  • a small amount of 02 may be introduced into the breathing circuit, for example, either directly into the mask (as shown at 417), or alternatively, on the side of the deadspace hose 403 closest to the cPAP.
  • the concentration of C02 in the deadspace 403 will be on a gradient (highest at the mask, lowest at the interface with the cPAP). As the patient breathes in the air accumulated in the deadspace 403, the concentration will change.
  • a computational algorithm is executed by the computer 413 to determine average inspired CO2, so that the desired level may be sustained.
  • PERIODIC BREATHING EMBODIMENT Periodic breathing in a patient tends to have a fairly fixed-time component.
  • the actual period of the oscillations is generally determined by physiological conditions that are reasonably fixed in the short term.
  • any periodic breathing patient tends to have well-defined cycles.
  • the principal determinant is the amount of time that it takes for changes in carbon dioxide levels to be sensed by the brain.
  • the breathing period tends to be about double that time. In most congestive heart failure patients, this results in an apnea-to-apnea period of approximately a minute and a half.
  • an embodiment of the invention can detect, using the NK sensor 42 (Fig. 2), where the patient is in the breathing cycle, and apply CO2 only at the appropriate time, e.g., when C02 levels are dropping. The effect is to abort the problematic breathing cycle altogether.
  • An advantage to this approach is the ability to deliver C02 to a patient who is not even on positive airway pressure, for example a waking congestive heart failure patient who is using a typical oxygen cannula.
  • the periodic breathing can be aborted by injecting C02 during inspiration for as few as three or four breaths. In this case, the C02 concentration may not be as critical, since C02 is injected into the airway circuit for only a short time.
  • This embodiment might not include positive airway pressure, and the exact mix of C02 may not be important.
  • the delivery mechanism might be as simple as injecting C02 in high concentrations into a loose-fitting facemask in a manner timed to coincide with the inspiration of a few breaths.
  • SIDS Sudden Infant Death Syndrome
  • ATE Apparent Life Threatening Experience
  • a PAPGAM may be useful in neonatal applications for inducing respiratory stability in this class of patients.
  • a PAPGAM may be connected to a patient centric ventilatory space module (PCVSM), such as an incubator, tent, facemask, nasal cannula, or similar device, with or without positive airway pressure.
  • PCVSM patient centric ventilatory space module
  • the gas might be sampled not from the mixing box, but rather from the incubator itself, or from both.
  • some embodiments will not employ a gas mixing module 20 of Fig. 1 but rather will achieve the proper combination of PAP (pressurized air) and C02 in some other means or in the PCVSM subsystem or the like.
  • Respiratory instability may be caused by a variety of conditions such as sleep apnea, renal failure, congestive heart failure and other conditions. It is understood from the foregoing discussion hat the present invention is applicable to each of these conditions.

Abstract

Selon la présente invention, des concentrations minimales de CO2 sont mélangées à de l'air sous pression afin d'obtenir un mélange de gaz efficace pour stabiliser la respiration de patients ou d'utilisateurs cibles. On utilise des concentrations en CO2 inférieures à environ 2 %, de préférence entre environ 0,5 % et 1,25 %. Un modulateur de gaz comprend un module de mélange de gaz (20), un capteur (36) et un processeur de commande (100). Le module de mélange de gaz mélange plusieurs gaz, notamment du CO2, pour former un mélange de gaz à fournir à un masque facial pour patient (48) sensiblement hermétique. Le capteur (42), situé principalement sur le masque facial, mesure une concentration en CO2 dans ce masque facial. Le processeur de commande, se basant sur un signal qui provient du capteur, commande la concentration en CO2 dans le mélange de gaz.
PCT/US2003/037236 2003-01-28 2003-11-21 Systemes a gaz et procedes pour permettre une stabilite respiratoire WO2004069317A1 (fr)

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CA002514481A CA2514481A1 (fr) 2003-01-28 2003-11-21 Systemes a gaz et procedes pour permettre une stabilite respiratoire
MXPA05008071A MXPA05008071A (es) 2003-01-28 2003-11-21 Sistemas y metodos de gas para permitir la estabilidad respiratoria.
AU2003291817A AU2003291817B2 (en) 2003-01-28 2003-11-21 Gas systems and methods for enabling respiratory stability
JP2004568008A JP2006513004A (ja) 2003-01-28 2003-11-21 呼吸を安定化する気体システムおよび方法
AT03769002T ATE434459T1 (de) 2003-01-28 2003-11-21 Gassysteme zur herstellung der atemstabilität
DE60328133T DE60328133D1 (de) 2003-01-28 2003-11-21 Gassysteme zur herstellung der atemstabilität
EP03769002A EP1590029B1 (fr) 2003-01-28 2003-11-21 Systemes a gaz pour permettre une stabilite respiratoire

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US60/443,227 2003-01-28

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US7886740B2 (en) 2011-02-15
WO2004069317A8 (fr) 2004-12-09
AU2003291817A1 (en) 2004-08-30
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US20040144383A1 (en) 2004-07-29
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EP1590029A1 (fr) 2005-11-02
MXPA05008071A (es) 2006-03-17

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